Assessing the Real-World, Long-Term Impact of Lemborexant on Sleep Quality in a Home-Based Clinical Study

Abstract

Purpose

Both subjective and objective evaluations are essential for the treatment of insomnia. Lemborexant has been shown to be effective in the long-term based solely on a subjective basis, and no long-term objective measures have been evaluated under natural sleep conditions. Small, lightweight sleep electroencephalogram (EEG) monitor was used, instead of polysomnography, to objectively evaluate sleep at home 4 and 12 weeks after lemborexant treatment.

Patients and Methods

Adults and elderly subjects with insomnia disorder, per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, were enrolled in this open-label, single-arm, single-center trial. Objective and subjective measures of sleep were prospectively assessed. Sleep disturbance, excessive sleepiness, and depressive symptoms were assessed using questionnaires.

Results

A total of 45 subjects were screened, of which 33 were enrolled. Paired t-tests were conducted to evaluate changes in sleep variables and compared with the baseline; subjects showed significant improvements in objective sleep efficiency (SE) and subjective sleep parameters at weeks 4 and 12 following treatment with lemborexant. When baseline values were taken into account, a repeated-multivariate analysis of variance (MANOVA) revealed statistically significant changes in the objective measures. Sleep disturbance, excessive sleepiness, and depressive symptoms improved after three months of lemborexant treatment.

Conclusion

Furthermore, lemborexant therapy improved nocturnal sleep, when measured objectively using sleep EEG monitoring at home, and improved daytime sleepiness and depressive symptoms in older adults with insomnia disorder.

Keywords:

• insomnia
• lemborexant
• objective sleep evaluation
• portable sleep EEG monitoring
• subjective sleep evaluation

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Acknowledgments

We thank Tomoko Wada, Keita Kawai, and Minami Kinouchi for their help with the data collection.

Disclosure

AF and YK are employees of Eisai Co., Ltd. KI reports personal fees from Eisai, Lundbeck Japan, MSD, Otsuka, Sumitomo Pharma, Takeda, Viatris, Yoshitomi, Meiji Seika Pharma, and Kyowa, outside the submitted work. TT reports grants from Canon Medical Systems, outside the submitted work. NO has received research support or speaker honoraria from, or has served as a joint researcher with, or a consultant to, Otsuka Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., Viatris Inc., Eisai Co., Ltd., The KAITEKI Institute, Inc., Ricoh Co., Ltd., Mitsubishi Tanabe Pharma Co.; reports personal fees/grants from Eli Lilly, DAIICHI SANKYO, TSUMURA, Takeda, Mochida, Meiji Seika Pharma, EA Pharma, Viatris, Ricoh, Nippon Boehringer Ingelheim, Lundbeck Japan, Nihon Medi-Physics, Nippon Chemiphar, outside the submitted work. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was financially supported by Eisai Co., Ltd., the owner and manufacturer of lemborexant.